MAUDE Adverse Event Report: CORDIS CORPORATION SABER035; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	48007010R
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, when flushing a 7mm x 100mm saber.035 percutaneous transluminal angioplasty (pta) balloon catheter with a syringe, saline squirted out of the proximal portion of the balloon.An unknown balloon catheter was used as a replacement to complete the procedure.There were no reported injuries to the patient.Additional information was requested but was not provided.The device will be returned for evaluation.Addendum: product evaluation revealed a leakage through the body/shaft of the saber pta balloon catheter.
Additional Manufacturer Narrative
Complaint conclusion: as reported, when flushing a 7mm x 100mm saber.035 percutaneous transluminal angioplasty (pta) balloon catheter with a syringe, saline squirted out of the proximal portion of the balloon.An unknown balloon catheter was used as a replacement to complete the procedure.There were no reported injuries to the patient.Additional information was requested but was not provided.The device was returned for evaluation.A non-sterile ¿saber.035 7x100 135cm sl¿ was received for analysis coiled inside of a clear plastic bag.The device was unpacked to be inspected.A thorough inspection was performed on the unit observing no damage.The received balloon was not inflated.No other outstanding details were noticed.Functional testing was performed, an inflator/deflator device was attached to the inflation port.Positive pressure was applied with the purpose of reaching the rated burst pressure.The balloon inflated as expected, no inflation difficulties or delays were observed, and the pressure remained steady.Negative pressure was applied, and the balloon was deflated as expected with no delays or any difficulties.The guidewire lumen was flushed with water and flowed through the distal tip as expected.However, a leakage was observed on the shaft.The area where the leakage occurred was inspected with a vision system observing a puncture on the shaft surface.Plastic deformations and secondary scratch marks are located near the damaged border area.This type of damage is commonly caused during the interaction of the material with a sharp object or mechanical damage.It seems that the material near the damaged area was affected by a sharp object from the outside of the device.The reported ¿body/shaft leakage¿ was visualized during device analysis.The exact cause could not be determined.Device analysis revealed a punctured condition and scratch marks adjacent to the body/shaft area.Based on the information provided it appears the body/shaft leakage was caused by the interaction of the shaft material with a sharp object.Vessel characteristics, although unknown and procedural factors likely contributed to the events reported.According to the instructions for use, which are not intended to mitigate risk, ¿prior to angioplasty, the catheter should be examined to verify functionality and integrity and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Do not use if product damage is suspected or evident.To reduce the potential for vessel damage or the risk of dislodgement of particles it is very important that the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the lesion.Proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.¿ neither the product analysis nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

• Brand Name: SABER035
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; coyol free zone, building b25, , , costa rica; el coyol alajuela bld 25 CR 2 -01 0 ; CS CR 2 01 02 ; 7863138372
• MDR Report Key: 22013425
• Report Number: 3007635982-2025-00108
• Device Sequence Number: 7837711
• Product Code: LIT
• UDI-Device Identifier: 20705032080146
• UDI-Public: (01)20705032080146(17)270331(10)82310414
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 48007010R
• Device Lot Number: 82310414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN BALLOON CATHETER.
• Patient Sex: Unknown